LUM-201 for Growth Hormone Deficiency
(OraGrowtH211 Trial)
Trial Summary
What is the purpose of this trial?
This is a multi-national trial. The trial aims to study the long-term safety of LUM-201 in subjects with Idiopathic Pediatric Growth Hormone Deficiency (iPGHD). This study will also assess pharmacodynamics and efficacy response to therapy with LUM-201.
Will I have to stop taking my current medications?
You may need to stop taking certain medications that affect the cytochrome system CYP3A4, which is involved in processing LUM-201. If you're on these medications for more than two weeks, you might not be able to participate, but shorter-term use will be evaluated individually.
What data supports the effectiveness of the drug LUM-201 for treating growth hormone deficiency?
Eligibility Criteria
This trial is for children with Idiopathic Pediatric Growth Hormone Deficiency who have already been part of a previous LUM-201 study. They must have completed at least 12 months in that study and be cleared to continue treatment. Children with conditions that add risk or those on certain long-term medications affecting LUM-201 metabolism cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Extension
Participants continue LUM-201 treatment to monitor long-term safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- LUM-201
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lumos Pharma
Lead Sponsor